The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
研究概览
简要总结
The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.
详细描述
The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of ~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than or equal to six months of age
- •Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
- •Availability of a study sonographer to perform bedside ultrasound
排除标准
- •Known spinal cord abnormality (e.g., tethered cord, spina bifida)
研究组 & 干预措施
US-Assisted site marking for Lumbar Punctures (LP)
Mindray M7 Ultrasound marking
干预措施: Bedside Ultrasound-Assisted Site Marking (Procedure)
US-Assisted site marking for Lumbar Punctures (LP)
Mindray M7 Ultrasound marking
干预措施: Mindray M7 Ultrasound (Device)
Routine lumbar puncture
These patients will receive no ultrasound-assisted site marking prior to lumbar puncture; The patients will simply have a "standard-of-care" spinal tap performed by the clinician
干预措施: Routine lumbar puncture (Procedure)
结局指标
主要结局
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
时间窗: 30 minutes
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
次要结局
- Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group(30 minutes)
- Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed for the duration of the hospital stay, an expected average of 2 days)
- Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed until discontinuation of antibiotics, an expected average of 2 days)
